Using Spectral Flow Cytometry for CAR T-Cell Clinical Trials: Game Changing Technologies Enabling Novel Therapies von Beadnell, Thomas C, Jasti, Susmita, Wang, Ruqi, Davis, Bruce H, Litwin, Virginia

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Flow Cytometry Method Validation Protocols von Selliah, Nithianandan, Eck, Steven, Green, Cherie, Oldaker, Teri, Stewart, Jennifer, Vitaliti, Alessandra, Litwin, Virginia

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Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part V – assay performance criteria von Wood, Brent, Jevremovic, Dragan, Béné, Marie C., Yan, Ming, Jacobs, Patrick, Litwin, Virginia

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Issue highlights—February 2024 von Litwin, Virginia

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Recommendations for the validation of flow cytometric testing during drug development: II assays von O'Hara, Denise M., Xu, Yuanxin, Liang, Zhiyan, Reddy, Manjula P., Wu, Dianna Y., Litwin, Virginia

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Issue Highlights—November 2021 von Litwin, Virginia

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5 Multiple myeloma flow cytometry panel validated for clinical monitoring of patients von Gang, Bevan, Sgouroudis, Vicky, Litwin, Virginia, Boyapati, Anita

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Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report von Mathews, Joel, Amaravadi, Lakshmi, Eck, Steven, Stevenson, Lauren, Wang, Yow-Ming C., Devanarayan, Viswanath, Allinson, John, Lundsten, Kelly, Gunsior, Michele, Ni, Yan G., Pepin, Marc-Olivier, Gagnon, Audrey, Sheldon, Curtis, Trampont, Paul C., Litwin, Virginia

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The Evolution of Single-Cell Analysis and Utility in Drug Development von Mitra-Kaushik, Shibani, Mehta-Damani, Anita, Stewart, Jennifer J., Green, Cherie, Litwin, Virginia, Gonneau, Christèle

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High‐sensitivity flow cytometric assays: Considerations for design control and analytical validation for identification of Rare events von Sommer, Ulrike, Eck, Steven, Marszalek, Laura, Stewart, Jennifer J., Bradford, Jolene, McCloskey, Thomas W., Green, Cherie, Vitaliti, Alessandra, Oldaker, Teri, Litwin, Virginia

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A Fit-for-Purpose Approach to Monitor Circulating Dendritic Cell Subpopulations for Clinical Investigation von Trampont, Paul Charles, Lourenco, Elaine, Czechowska-Kusio, Kamila, Litwin, Virginia

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Flow cytometric method transfer: Recommendations for best practice von Cabanski, Maciej, Oldaker, Teri, Stewart, Jennifer J., Selliah, Nithianandan, Eck, Steve, Green, Cherie, Litwin, Virginia, Vitaliti, Alessandra

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ICCS/ESCCA Consensus Guidelines to detect GPI‐deficient cells in Paroxysmal Nocturnal Hemoglobinuria (PNH) and related Disorders Part 4 – Assay Validation and Quality Assurance von Oldaker, Teri, Whitby, Liam, Saber, Maryam, Holden, Jeannine, Wallace, Paul K, Litwin, Virginia

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Flow Cytometry Method Validation Protocols von Selliah, Nithianandan, Nash, Veronica, Eck, Steven, Green, Cherie, Oldaker, Teri, Stewart, Jennifer, Vitaliti, Alessandra, Litwin, Virginia

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Progress towards global standardization for quantitative flow cytometry von Gonneau, Christele, Wang, Lili, Mitra-Kaushik, Shibani, Trampont, Paul C., Litwin, Virginia

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Correction: Flow Cytometry Method Validation Protocols von Selliah, Nithianandan, Nash, Veronica, Eck, Steven, Green, Cherie, Oldaker, Teri, Stewart, Jennifer, Vitaliti, Alessandra, Litwin, Virginia

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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations o... von Piccoli, Steven, Mehta, Devangi, Vitaliti, Alessandra, Allinson, John, Amur, Shashi, Eck, Steve, Green, Cherie, Hedrick, Michael, Hopper, Shirley, Ji, Allena, Joyce, Alison, Litwin, Virginia, Maher, Kevin, Mathews, Joel, Peng, Kun, Safavi, Afshin, Wang, Yow-Ming, Zhang, Yan, Amaravadi, Lakshmi, Palackal, Nisha, Thankamony, Sai, Beaver, Chris, Bame, Eris, Emrich, Thomas, Grimaldi, Christine, Haulenbeek, Jonathan, Kakkanaiah, Vellalore, Lanham, David, Mayer, Andrew, Trampont, Paul C, Vermet, Laurent, Dakappagari, Naveen, Fleener, Catherine, Garofolo, Fabio, Rogers, Cynthia, Tangri, Shabnam, Xu, Yuanxin, Liang, Meina, Rajadhyaksha, Manoj, Richards, Susan, Schweighardt, Becky, Purushothama, Shobha, Baltrukonis, Daniel, Brumm, Jochen, Cherry, Elana, Delcarpini, Jason, Gleason, Carol, Kirshner, Susan, Kubiak, Robert, Pan, Luying, Partridge, Michael, Pedras-Vasconcelos, João, Qu, Qiang, Skibeli, Venke, Saunders, Therese Solstad, Staack, Roland F, Stubenrauch, Kay, Torri, Al, Verthelyi, Daniela, Yan, Haoheng, Gorovits, Boris, Palmer, Rachel, Milton, Mark, Long, Brian, Corsaro, Bart, Farrokhi, Vahid, Fiscella, Michele, Henderson, Neil, Jawa, Vibha, McNally, Jim, Murphy, Rocio, Waldner, Hanspeter, Yang, Tong-Yuan

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Receptor occupancy by flow cytometry von Litwin, Virginia, Green, Cherie, Stewart, Jennifer J.

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Flow cytometry assay modifications: Recommendations for method validation based on CLSI H62 guidelines von Monaghan, Sara A, Eck, Steven, Bunting, Silvia, Dong, Xiangyang X, Durso, Robert J, Gonneau, Christele, Hays, Amanda, Illingworth, Andrea, League, Stacy C, Linskens, Eleni, McCausland, Megan, McCloskey, Thomas W, Rolf, Nina, Shi, Min, Wallace, Paul K, Litwin, Virginia, Kern, Wolfgang, Deeb, George, Nash, Veronica, Olteanu, Horatiu

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Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum von der Strate, Barry van, Longdin, Robin, Geerlings, Marie, Bachmayer, Nora, Cavallin, Maria, Litwin, Virginia, Patel, Minesh, Passe-Coutrin, Wilfried, Schoelch, Corinna, Companjen, Arjen, Fjording, Marianne Scheel

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